Case Volume and Adenoma Rate During Screening Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Case Volume and Adenoma Detection Rates During Screening Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860665
• Other study ID #: BECOP-3
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: March 11, 2009
• Start date: October 2006
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate.

Description:

21 private practice gastroenterologist endoscopists from Berlin performed a prospective quality assessment study including at least 10.000 screening colonoscopies. After informed consent, patients data are included (age, sex, family history, colonoscopy performance parameters and findings, therapy performed, histology of biopsies and/or polypectomies, complications (immediate and late) and patient acceptance. The latter was retrieved by patient questionnaires returned after a minimum of 2 weeks. Data were centrally collected in an anonymized way

Primary outcome parameter:

• Correlation of adenoma detection rate with case volume and other confounding factors (e.g., withdrawal time)

Secondary outcome parameters:

• Complications and method of assessment (immediate recording versus later questionnaire enquiry)

• Quality of bowel preparation in relation to outcome Patient acceptance in relation to procedural factors (e.g., sedation)

• Quality of pathology reports and histologic outcome of polypectomy

Later follow-up (after 5-10 years) of the preventive effect of colonoscopy is planned and has been part of the protocol and patient consent form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12134
• Est. completion date: March 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• all persons willing and able to undergo screening colonoscopy over the age of 55 years

Exclusion Criteria:

• any condition not compatible with the definition of screening colonoscopy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Germany	Charité Medical University Berlin Campus Virchow	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Interest group of Berlin private practice gastroenterologists

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of adenoma detection rate with case volume of endoscopists		18 months	No
Secondary	Patient acceptance in relation to procedural factors (e.g. sedation)		18 months	No